ISOVUE-370 Drug Patent Profile

When do Isovue-370 patents expire, and when can generic versions of Isovue-370 launch?

Isovue-370 is a drug marketed by Bracco and is included in two NDAs.

The generic ingredient in ISOVUE-370 is iopamidol. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iopamidol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Isovue-370

A generic version of ISOVUE-370 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for ISOVUE-370

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	20
Patent Applications:	3,767
Drug Prices:	Drug price information for ISOVUE-370
DailyMed Link:	ISOVUE-370 at DailyMed

See drug prices for ISOVUE-370

Recent Clinical Trials for ISOVUE-370

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
NYU Langone Health	N/A
M.D. Anderson Cancer Center	N/A
National Cancer Institute (NCI)	N/A

See all ISOVUE-370 clinical trials

Pharmacology for ISOVUE-370

Drug Class	Radiographic Contrast Agent
Mechanism of Action	X-Ray Contrast Activity

US Patents and Regulatory Information for ISOVUE-370

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	ISOVUE-370	iopamidol	INJECTABLE;INJECTION	018735-003	Dec 31, 1985	AP	RX	Yes	Yes
Bracco	ISOVUE-370	iopamidol	INJECTABLE;INJECTION	020327-004	Oct 12, 1994		RX	Yes	Yes

Expired US Patents for ISOVUE-370

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	ISOVUE-370	iopamidol	INJECTABLE;INJECTION	018735-003	Dec 31, 1985	4,001,323
Bracco	ISOVUE-370	iopamidol	INJECTABLE;INJECTION	020327-004	Oct 12, 1994	4,001,323

International Patents for ISOVUE-370

See the table below for patents covering ISOVUE-370 around the world.

Country	Patent Number	Title	Estimated Expiration
Switzerland	608189
Canada	1046082	DERIVES DE L'ACIDE TRIIODO-2,4,6 ISOPHTHALIQUE (DERIVATIVES OF 2,4,6-TRIIODO-ISOPHTHALIC ACID)
Austria	349449
Bulgaria	26512
Norway	145096
United Kingdom	1472050

ISOVUE-370 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ISOVUE-370

Introduction

ISOVUE-370, a nonionic radiopaque contrast medium, is a crucial diagnostic tool in medical imaging, particularly in angiography and computed tomography (CT) scans. Developed by Bracco Diagnostics, ISOVUE-370 has carved a significant niche in the medical imaging market. Here, we delve into the market dynamics and financial trajectory of this important medical product.

Market Indications and Uses

ISOVUE-370 is indicated for various diagnostic procedures, including angiography throughout the cardiovascular system, cerebral and peripheral arteriography, coronary arteriography, and left ventriculography. It is also used for intravenous contrast enhancement in CT scans of the head and body[1][5].

Competitive Landscape

The market for contrast media is competitive, with several other products available, such as Visipaque and Omnipaque. However, ISOVUE-370 stands out due to its high radiopacity and accuracy in aneurysm measurements, making it a preferred choice for certain procedures[3].

Unique Selling Points

• High Radiopacity: ISOVUE-370 provides the highest Hounsfield Unit (HU) radiopacity, which is crucial for accurate imaging, especially in aneurysm measurements[3].
• Multidose Packaging: The Imaging Bulk Package of ISOVUE-370 is designed for multiple single doses for multiple patients, improving sustainability, reducing waste, and conserving iodine. This feature also helps in reducing costs associated with contrast waste and enhances resource efficiency[2].
• Broad Range of Applications: ISOVUE-370 is versatile and can be used in a variety of diagnostic procedures, from cerebral arteriography to coronary arteriography and CT scans of the body[1][5].

Market Demand

The demand for contrast media like ISOVUE-370 is driven by the increasing need for diagnostic imaging in healthcare. Factors such as the rising incidence of cardiovascular diseases, the growing aging population, and advancements in medical technology contribute to the steady demand for these products.

Financial Performance

The financial performance of ISOVUE-370 can be gauged through several key metrics:

Revenue Growth

ISOVUE-370, as part of Bracco Diagnostics' portfolio, contributes significantly to the company's revenue. The product's unique features and broad applications ensure a steady stream of revenue. The market for contrast media is expected to grow, driven by the increasing demand for diagnostic imaging, which in turn is likely to boost the revenue from ISOVUE-370.

Cost Efficiency

The multidose packaging of ISOVUE-370 helps in reducing costs associated with contrast waste. This cost-efficient approach not only benefits healthcare providers but also contributes to the product's financial viability by reducing overall expenditure on contrast media[2].

Market Share

ISOVUE-370 holds a significant market share in the contrast media segment due to its high radiopacity and the advantages of its multidose packaging. The product's market share is expected to remain strong as it continues to be a preferred choice for various diagnostic procedures.

Regulatory Environment

ISOVUE-370 is FDA-approved and manufactured at several locations, including Germany and Italy. Compliance with regulatory standards is crucial for the product's continued market presence. Any changes in regulatory requirements could impact the product's financial trajectory, but Bracco Diagnostics' adherence to strict manufacturing and safety standards ensures ongoing approval and market stability[2].

Safety and Efficacy

The safety and efficacy of ISOVUE-370 are well-documented. The product does not cross the blood-brain barrier to a significant extent and does not activate the complement system in normal subjects. These characteristics contribute to its favorable safety profile, which is essential for maintaining market confidence and driving financial performance[1].

Patient and Healthcare Provider Preferences

Healthcare providers prefer ISOVUE-370 due to its high radiopacity and the accuracy it provides in diagnostic imaging. Patients benefit from the precise diagnoses that can be made using this contrast medium, which in turn influences healthcare providers to choose ISOVUE-370 over other options.

Future Outlook

The future outlook for ISOVUE-370 is promising, driven by the increasing demand for advanced diagnostic imaging. Here are a few key points:

• Technological Advancements: Continued advancements in medical imaging technology are likely to enhance the utility and demand for ISOVUE-370.
• Expanding Applications: Potential new applications in emerging fields like interventional radiology could further boost the product's market presence.
• Sustainability: The multidose packaging and iodine conservation features align with the growing emphasis on sustainability in healthcare, which could attract more environmentally conscious healthcare providers.

Key Takeaways

• ISOVUE-370 is a highly effective contrast medium with high radiopacity and accuracy in diagnostic imaging.
• Its multidose packaging enhances sustainability and reduces costs.
• The product has a strong market presence due to its broad range of applications and favorable safety profile.
• The financial trajectory of ISOVUE-370 is expected to remain positive, driven by increasing demand for diagnostic imaging and technological advancements.

FAQs

What is ISOVUE-370 used for?

ISOVUE-370 is used for various diagnostic procedures, including angiography throughout the cardiovascular system, cerebral and peripheral arteriography, coronary arteriography, and left ventriculography, as well as for intravenous contrast enhancement in CT scans of the head and body[1][5].

What makes ISOVUE-370 unique?

ISOVUE-370 provides the highest Hounsfield Unit (HU) radiopacity, making it highly accurate for diagnostic imaging, especially in aneurysm measurements. It also comes in a multidose packaging that improves sustainability and reduces waste[2][3].

Is ISOVUE-370 safe to use?

Yes, ISOVUE-370 has a favorable safety profile. It does not cross the blood-brain barrier to a significant extent and does not activate the complement system in normal subjects[1].

How does ISOVUE-370 impact healthcare costs?

The multidose packaging of ISOVUE-370 helps reduce costs associated with contrast waste, making it a cost-efficient option for healthcare providers[2].

What is the future outlook for ISOVUE-370?

The future outlook is promising, driven by increasing demand for advanced diagnostic imaging, technological advancements, and the product's alignment with sustainability goals in healthcare.

References

1. FDA Label: ISOVUE (lopamidol Injection) - accessdata.fda.gov
2. ISOVUE Website: ISOVUE - ISOVUE
3. Wiley Online Library: Differences in radiopacity among CT contrast agents and ...
4. DrugBank: Iopamidol: Uses, Interactions, Mechanism of Action | DrugBank Online
5. Product Monograph: ISOVUE - [Product Monograph Template - Standard]